Design plan of the medicine store following intended alteration, which should at least include the following compartments, furniture and equipment (Notes 1 and 2):

Compartments:

Medication dispensing room or reception room;

Medicine storage;

Lavatory;

Furniture and equipment:

Glass cabinet for storing medicines in the medication dispensing room;

Reception desk;

Cabinet for storing other products;

Refrigerator for storing medicines that require cold storage;

Air ventilation and air conditioning systems (which must be placed inside the medication dispensing room or reception room, and the medicine storage).

If the intended alteration involves expansion of the premise, the medicine store shall submit the following documents for the extension:

Building utilisation permit issued by the Land, Public Works and Transport Bureau or the original Property Registration Report issued by the Real Estate Registry (Premises registered with the Real Estate Registry are exempted from submitting this document, Note 3);

Photocopy of the updated Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 4).

If the intended alteration involves downsizing of the premise, the medicine store shall submit a photocopy of the updated Business Tax Declaration Form (M/1 format) obtained from the Financial Services Bureau (Note 4).

Notes:

The plan of the premise shall be signed by the applicant, or an executive management member legitimately representing the company when the applicant is a legal person;

Fees

(Subject to 10% stamp duty; full amount payable upon submission of the application.)

Note: ‘The fees paid will not be returned if the application is rejected or filed,’ according to Paragraph 5 of Article 21 of Decree-Law No. 58/90/M dated 19th September.

Application Processing Time

The Health Bureau will finish the review and approval process within 90 days upon receipt of all the documents required, and will issue an authorisation for premise establishment in the case of approval. The time needed for licence issuance depends on the progress of premise establishment and the processes of statutory inspection.

Sanctions

1. In accordance with the provisions of Paragraph 5 of Article 17 and Paragraph 1 of Article 89 of Decree-Law No. 58/90/M dated 19th September, selling medicines without a licence is punishable by a fine of between MOP 4,000 and MOP 12,000.

2. In accordance with the provisions of Paragraph 1 of Article 18 and Paragraph 1 of Article 88 of Decree-Law No. 58/90/M dated 19th September, commencing business before a licence is granted is punishable by a fine of between MOP 5,000 to MOP 12,000.

3. In accordance with the provisions of Paragraph 1 of Article 18 and Paragraph 2 of Article 88 of Decree-Law No. 58/90/M dated 19th September, commencing business before applying for a licence or after the application has been rejected is punishable by a fine of between MOP 9,000 to MOP 12,000.

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